Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
Study NCT ID:
NCT04185350
Status:
UNKNOWN
Last Update Posted:
2019-12-04
First Post:
2019-12-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007340', 'term': 'Insulinoma'}], 'ancestors': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value', 'timeFrame': '1 year', 'description': 'Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma'}], 'secondaryOutcomes': [{'measure': 'GLP-1 receptor expression by histology compared to tracer uptake', 'timeFrame': '1 year', 'description': "Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT"}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Adverse events within 1 week after the injection and scanning of patients will be followed and assessed', 'description': 'This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulinoma']}, 'descriptionModule': {'briefSummary': 'Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.', 'detailedDescription': 'Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-MAL-Cys39-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient volunteers and signs an informed consent form.\n2. age ≥18 and ≤75 years old;\n3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;\n4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \\<3.0 mM, insulin \\>3 µU/ml, and C-peptide \\>0.6 ng/ml);\n5. Conventional imaging within 3 month.\n\nExclusion Criteria:\n\n1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;\n2. Breast feeding;\n3. Pregnancy or the wish to become pregnant within 6 months;\n4. Renal function: serum creatinine \\> 3.0 mg/dl;\n5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance."}, 'identificationModule': {'nctId': 'NCT04185350', 'briefTitle': 'Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma', 'orgStudyIdInfo': {'id': 'NJCNMC-GLP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT', 'description': 'The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.', 'interventionNames': ['Drug: 68Ga-NOTA-MAL-Cys39-exendin-4']}], 'interventions': [{'name': '68Ga-NOTA-MAL-Cys39-exendin-4', 'type': 'DRUG', 'description': 'After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.', 'armGroupLabels': ['68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengjun Zhang, M.S', 'role': 'CONTACT', 'email': 'pengjunmr@163.com', 'phone': '+8602552271456'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Feng Wang, Ph.D', 'role': 'CONTACT', 'email': 'fengwangcn@hotmail.com', 'phone': '+8602552271491'}], 'overallOfficials': [{'name': 'Feng Wang, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nuclear Medicine', 'investigatorFullName': 'FengWang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}